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Sargramostim
Leukine (sargramostim) is a protein pharmaceutical. Sargramostim was first approved as Leukine on 1991-03-05. It is used to treat breast neoplasms, hodgkin disease, neutropenia, non-hodgkin lymphoma, and precursor cell lymphoblastic leukemia-lymphoma in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Leukine
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Sargramostim
Tradename
Proper name
Company
Number
Date
Products
LeukinesargramostimPartner TherapeuticsN-103362 RX1991-03-05
1 products
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
leukineBiologic Licensing Application2020-12-16
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
hodgkin disease—D006689C81
neutropenia—D009503D70
non-hodgkin lymphoma—D008228C85.9
precursor cell lymphoblastic leukemia-lymphoma—D054198C91.0
Agency Specific
FDA
EMA
Expiration
Code
sargramostim, Leukine, Partner Therapeutics, Inc.
2025-03-29Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L03: Immunostimulants
— L03A: Immunostimulants
— L03AA: Colony stimulating factors
— L03AA09: Sargramostim
HCPCS
Code
Description
J2820
Injection, sargramostim (gm-csf), 50 mcg
Clinical
Clinical Trials
3 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Congenital sucrase-isomaltase deficiencyC538139E74.31———2—2
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSARGRAMOSTIM
INNsargramostim
Description
Granulocyte-macrophage colony-stimulating factor [Precursor]
Classification
Protein
Drug classcolony-stimulating factors: granulocyte macrophage colony-stimulating factors (GM-CSF); colony-stimulating factors: macrophage colony-stimulating factors (M-CSF)
Image (chem structure or protein)SARGRAMOSTIM
Structure (InChI/SMILES or Protein Sequence)
>6BFS:H|Fab Heavy Chain EVKLQQSGPELVKPGASVKISCKASGYSFTNYYMHWMKQRPGQGLEWIGWIFPGSDNTKYNEKFKGKATLTADTSSSTAY MQLSSLTSEDSAVYFCARKGTTGFAYWGQGTLVTVSAAKTTPPSVYPLAPGSAAQTNSMVTLGCLVKGYFPEPVTVTWNS GSLSSGVHTFPAVLQSDLYTLSSSVTVPSSTWPSETVTCNVAHPASSTKVDKKIVPR >6BFS:L|Fab light Chain DIQLTQSPSSLSASLGDTITITCHASQNINVWLSWYQQKPGNIPKLLIYKASNLHTGVPSRFSGSGSGTGFTLTISSLQP EDIATYYCQQGQSYPLTFGGGTKLEIKRADAAPTVSIFPPSSEQLTSGGASVVCFLNNFYPKDINVKWKIDGSERQNGVL NSWTDQDSKDSTYSMSSTLTLTKDEYERHNSYTCEATHKTSTSPIVKSFNRNEC
Identifiers
PDB4NKQ, 4RS1, 5C7X, 5D70, 5D71, 5D72, 6BFQ, 6BFS
CAS-ID—
RxCUI69634
ChEMBL IDCHEMBL1201670
ChEBI ID—
PubChem CID—
DrugBankDB00020
UNII ID5TAA004E22 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,650 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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53 adverse events reported
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